Colorectal CancerNCT00675636
Collecting Information From Patients and Family Members With Hereditary Colorectal Cancer Syndromes or Who Are at High Risk of Developing Colorectal Cancer
An observational study of Colorectal Cancer and Hereditary Non-polyposis Colon Cancer, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial summary
RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Colorectal Cancer, Hereditary Non-polyposis Colon Cancer, Precancerous Condition
- What is being tested?
- study of socioeconomic and demographic variables, evaluation of cancer risk factors and study of high risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 730 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Anyone with known or suspected hereditary colorectal cancer syndrome, early age o onset of colorectal cancer (see below).
DISEASE CHARACTERISTICS:
- Meets any of the following criteria:
- Patients and family members with a known hereditary colorectal cancer or polyposis syndrome
- Patients who meet Amsterdam I, II, or Bethesda criteria
- Patients with a family history suggestive of a hereditary colorectal or polyposis syndrome
- Patients diagnosed with colorectal cancer at < 50 years old
- Patients are identified through surgical, oncological, gynecological, and gastrointestinal programs, as well as outside referrals, self referral, and the Vanderbilit Tumor Registry
PATIENT CHARACTERISTICS:
- See Disease Characteristics
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Vanderbilt Hereditary Colorectal Cancer Registry
RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.
Read the detailed description
OBJECTIVES:
Primary
- To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
Secondary
- To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.
- Being tested
- study of socioeconomic and demographic variables, evaluation of cancer risk factors, study of high risk factors
- Keywords
- colon cancer, hereditary non-polyposis colon cancer, rectal cancer, familial adenomatous polyposis
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Precancerous Conditions, Colonic Neoplasms, Rectal Neoplasms, Adenomatous Polyposis Coli
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study of socioeconomic and demographic variablesOther
database, no intervention
evaluation of cancer risk factorsProcedure or surgery
database, no intervention
study of high risk factorsProcedure or surgery
database, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of patients at high risk of developing hereditary colorectal cancer
Database will continue indefinitely with IRB approval and investigator support
Measured: continuous data collection
Secondary outcomes (1)
Establishment of a tissue and data repository
Measured: continuous data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startJan 2007
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Molly Cone, Vanderbilt University Medical Center
- Investigators
- Paul Wise, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675636
- Sponsor's protocol ID
- CDR0000587344
- Other IDs
- P30CA068485, VU-VICC-GI-0721, VU-VICC-061182
- Status last verified
- Aug 2017
- First submitted
- 8 May 2008
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt Hereditary Colorectal Cancer Registry
- ClinicalTrials.gov ID
- NCT00675636
- Acronym / sponsor ID
- CDR0000587344
- Keywords
- colon cancer, hereditary non-polyposis colon cancer, rectal cancer, familial adenomatous polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Gathering medical and family history information from patients and family members may help doctors better understand hereditary colorectal cancer and hereditary polyposis syndrome and identify patients at high risk of developing hereditary colorectal cancer.
PURPOSE: This research study is collecting information from patients and family members with hereditary colorectal cancer or polyposis syndrome or who are at high risk of developing hereditary colorectal cancer.
Detailed description
OBJECTIVES:
Primary
- To identify patients and their family members who have either hereditary colorectal cancer or polyposis syndrome or are at high risk for developing hereditary colorectal cancer.
Secondary
- To establish a tissue and data repository that will be used to further research in hereditary colorectal cancer syndromes.
OUTLINE: Data is collected on patients and their families for inclusion in a hereditary colorectal cancer registry. Registry data is entered into a secure database that includes information on patient demographics and medical and family cancer history. The information collected will be used to formulate screening and surveillance recommendations, to further knowledge of hereditary colorectal cancer, and to facilitate cancer research. Registry data will also be used to improve the quality of current standard of care through timely tracking and notification of patients for follow-up care, identification of registry participants at high risk for developing an inherited form of colon cancer, and by serving as a resource for future research.
Registry patients may undergo optional blood, urine, and/or sputum sample collection for inclusion in the tissue repository. Tissue samples from a previous biopsy may also be obtained. Samples will be stored for future research studies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone with known or suspected hereditary colorectal cancer syndrome, early age o onset of colorectal cancer (see below).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study of socioeconomic and demographic variablesdatabase, no intervention | Other | – |
| evaluation of cancer risk factorsdatabase, no intervention | Procedure or surgery | – |
| study of high risk factorsdatabase, no intervention | Procedure or surgery | – |
Primary outcome
Identification of patients at high risk of developing hereditary colorectal cancer
Time frame: continuous data collection
Database will continue indefinitely with IRB approval and investigator support
1 secondary outcome
Establishment of a tissue and data repository
Time frame: continuous data collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Wise, MD study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Hereditary Non-polyposis Colon Cancer, run by Vanderbilt University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of patients at high risk of developing hereditary colorectal cancer (time frame: continuous data collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2017.